“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
Neurostimulation system GENESIS: is indicated as an aid in the treatment of chronic pain, not treatable with other therapies of the trunk or extremities including unilateral or bilateral pain associated with any of the following cases: syndrome of failure of the back surgery, as well as back pain and pain in lower limbs difficult to cure. EON / EON MINI neurostimulation system: are indicated for the treatment of chronic and intractable pain of the trunk and / or extremities, including unilateral or bilateral pain associated with some of the following cases; failure syndrome of back surgery, as well as low back pain and pain in lower limbs difficult to cure. MULTIPROGRAM TRIALSTIMULATOR system: it is used for the stimulation of the spinal cord (eme) in the treatment of chronic trunk pain and extremities, either as an individual palliative method or with other types of treatment in the case of pluridisciplinary therapy. This system of modular stimulation is indicated as adjuvant in the treatment of chronic pain in the trunk and extremities, including unilateral or bilateral pain associated with angina pectoris and peripheral vascular disease.